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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that this patient¿s generator had a very short battery life and therefore it is believed to have prematurely depleted. No other relevant information has been received to date.

 
Event Description

The dhr of the generator was reviewed, and the device passed all functional specifications prior to release. The trim test tab operation was performed during a time in which model 106 generators were not laser-routed. The patient received a generator replacement, stated to be due to battery depletion, and the explanted generator has been received by the manufacturer. Product analysis is underway but has not been completed to date. Multiple attempts for relevant information were made, but no information has been received to date. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7776398
Report Number1644487-2018-01382
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2017
Device MODEL Number106
Device LOT Number203359
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/09/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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